Adverse Events Module

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Adverse Events Module

For researchers submitting trial data to ClinicalTrials.gov, the Adverse Events module is one of four mandatory results sections. It requires reporting in three primary categories: All-Cause Mortality: A table tracking all deaths that occurred during the study, regardless of cause. Serious Adverse Events (SAEs): A tabular summary of events resulting in death, life-threatening conditions, hospitalization, or significant disability. Other Adverse Events: A table for non-serious events that exceed a specific frequency threshold, such as 5% within any study arm.

Adverse Events Module path is as follows:

Study -> Results Section -> Adverse Events Module -> Event Groups

Study -> Results Section -> Adverse Events Module -> Serious Events

Study -> Results Section -> Adverse Events Module -> Other Events

Adverse Events Module

Ignite Creation Date: 2025-12-24 @ 5:01 PM
Ignite Modification Date: 2025-12-25 @ 2:41 PM
NCT ID: NCT02092350
Description: AE data is presented for APaT (all participants receiving ≥1 dose of study drug).
Frequency Threshold: 5
Time Frame: Immediate Treatment + Intensive PK: up to Week 36; Deferred Treatment GZR Placebo + EBR Placebo: up to Week 16; Deferred Treatment GZR 100 mg + EBR 50 mg: Week 16 to up to Week 52.
Study: NCT02092350
Study Brief: Safety and Efficacy of Grazoprevir (MK-5172) + Elbasvir (MK-8742) in Participants With Chronic Hepatitis C and Chronic Kidney Disease (MK-5172-052)
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Immediate Treatment + Intensive PK Participants received GZR 100 mg tablet + EBR 50 mg tablet q.d. by mouth for 12 weeks, followed by a 24-week follow-up period. A subset of participants also underwent intensive PK testing. None None 30 122 67 122 View
Deferred Treatment: GZR Placebo + EBR Placebo 12 Weeks Participants received placebo to GZR and EBR q.d. by mouth for 12 weeks, followed by a 4-week drug-free period. None None 22 113 68 113 View
Deferred Treatment: GZR 100 mg + EBR 50 mg 12 Weeks Participants received a FDC tablet containing GZR 100 mg + EBR 50 mg q.d. by mouth for 12 weeks, followed by a 24-week follow-up period. None None 25 102 39 102 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Acute myocardial infarction SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 16.0 View
Atrial fibrillation SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 16.0 View
Cardiac arrest SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 16.0 View
Cardiac failure congestive SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 16.0 View
Cardiomyopathy SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 16.0 View
Myocardial infarction SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 16.0 View
Abdominal pain SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 16.0 View
Abdominal pain upper SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 16.0 View
Constipation SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 16.0 View
Diarrhoea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 16.0 View
Gastritis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 16.0 View
Localised intraabdominal fluid collection SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 16.0 View
Pancreatitis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 16.0 View
Upper gastrointestinal haemorrhage SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 16.0 View
Vomiting SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 16.0 View
Chest pain SYSTEMATIC_ASSESSMENT General disorders MedDRA 16.0 View
Citrobacter sepsis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 16.0 View
Enterobacter sepsis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 16.0 View
Haematoma infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 16.0 View
Infected fistula SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 16.0 View
Lower respiratory tract infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 16.0 View
Osteomyelitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 16.0 View
Pneumonia SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 16.0 View
Postoperative wound infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 16.0 View
Sepsis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 16.0 View
Arteriovenous fistula aneurysm SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 16.0 View
Arteriovenous fistula site complication SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 16.0 View
Dialysis related complication SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 16.0 View
Foreign body SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 16.0 View
Genital injury SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 16.0 View
Postoperative fever SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 16.0 View
Procedural pain SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 16.0 View
Wound dehiscence SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 16.0 View
Blood alkaline phosphatase increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 16.0 View
Electrocardiogram abnormal SYSTEMATIC_ASSESSMENT Investigations MedDRA 16.0 View
Lipase increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 16.0 View
Dehydration SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 16.0 View
Fluid overload SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 16.0 View
Hyperglycaemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 16.0 View
Hyperkalaemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 16.0 View
Costochondritis SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 16.0 View
Intervertebral disc protrusion SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 16.0 View
Myositis SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 16.0 View
Papillary thyroid cancer SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 16.0 View
Prostate cancer SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 16.0 View
Depressed level of consciousness SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 16.0 View
Dizziness SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 16.0 View
Pleural effusion SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 16.0 View
Aortic aneurysm SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 16.0 View
Cryoglobulinaemia SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 16.0 View
Extremity necrosis SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 16.0 View
Hypertension SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 16.0 View
Hypertensive crisis SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 16.0 View
Orthostatic hypotension SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 16.0 View
Peripheral venous disease SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 16.0 View
Shock haemorrhagic SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 16.0 View
Iron deficiency anaemia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA v. 18.0 View
Coronary artery occlusion SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA v. 18.0 View
Pericardial effusion SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA v. 18.0 View
Pericarditis SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA v. 18.0 View
Tricuspid valve incompetence SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA v. 18.0 View
Gastrointestinal haemorrhage SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA v. 18.0 View
Retroperitoneal haematoma SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA v. 18.0 View
Gastroenteritis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA v. 18.0 View
Mediastinitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA v. 18.0 View
Nocardiosis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA v. 18.0 View
Pneumonia bacterial SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA v. 18.0 View
Septic shock SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA v. 18.0 View
Urinary tract infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA v. 18.0 View
Facial bones fracture SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA v. 18.0 View
Post procedural haematoma SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA v. 18.0 View
Subdural haematoma SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA v. 18.0 View
Encephalopathy SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA v. 18.0 View
Hepatic encephalopathy SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA v. 18.0 View
Hydrocephalus SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA v. 18.0 View
Intraventricular haemorrhage SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA v. 18.0 View
Nervous system disorder SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA v. 18.0 View
Disorientation SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA v. 18.0 View
Acute kidney injury SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA v. 18.0 View
Chronic kidney disease SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA v. 18.0 View
Tubulointerstitial nephritis SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA v. 18.0 View
Acute pulmonary oedema SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA v. 18.0 View
Chronic obstructive pulmonary disease SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA v. 18.0 View
Hypoxia SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA v. 18.0 View
Mediastinal effusion SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA v. 18.0 View
Pneumothorax SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA v. 18.0 View
Pulmonary oedema SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA v. 18.0 View
Aortic stenosis SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA v. 18.0 View
Angina unstable SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 16.0 View
Death SYSTEMATIC_ASSESSMENT General disorders MedDRA 16.0 View
Non-cardiac chest pain SYSTEMATIC_ASSESSMENT General disorders MedDRA 16.0 View
Pyrexia SYSTEMATIC_ASSESSMENT General disorders MedDRA 16.0 View
Abscess limb SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 16.0 View
Appendicitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 16.0 View
Headache SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 16.0 View
Hemiparesis SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 16.0 View
Presyncope SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 16.0 View
Acute respiratory failure SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 16.0 View
Anaemia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA v. 18.0 View
Hyponatraemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA v. 18.0 View
Pain in extremity SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA v. 18.0 View
Aortic stenosis SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA v. 18.0 View
Cardiac failure SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA v. 18.0 View
Seizure SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA v. 18.0 View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Vomiting SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 16.0 View
Decreased appetite SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 16.0 View
Headache SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 16.0 View
Hypertension SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 16.0 View
Abdominal discomfort SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 16.0 View
Abdominal pain SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 16.0 View
Constipation SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 16.0 View
Diarrhoea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 16.0 View
Nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 16.0 View
Asthenia SYSTEMATIC_ASSESSMENT General disorders MedDRA 16.0 View
Fatigue SYSTEMATIC_ASSESSMENT General disorders MedDRA 16.0 View
Pyrexia SYSTEMATIC_ASSESSMENT General disorders MedDRA 16.0 View
Musculoskeletal pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 16.0 View
Myalgia SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 16.0 View
Dizziness SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 16.0 View
Insomnia SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 16.0 View
Cough SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 16.0 View
Pruritus SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 16.0 View